Rectal CancerNCT04779125
APEMESH II - Perineal Reconstruction
A study testing Gluteus plasty enhanced with Progrip self gripping mesh in people with Rectal Cancer, run by University of Oulu at 1 site in Finland.
Trial summary
The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Gluteus plasty enhanced with Progrip self gripping mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 19 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Curative intent abdominoperineal resection and permanent colostomy
Who cannot join
- Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)
- Immunosupression (cortisone >10mg/day) or severe malnutrition (BMI <20)
- Diabetes with 1 or more organ damage
- Dialysis treatment
- Hepatic cirrhosis Child-Bugh B-C
- Potentially curable resection not possible
Show all 12Show fewer
- Patient undergoing emergency procedures
- Metastatic disease
- Vaginal resection, pelvic exenteration and sacrum resection
- Vaginal perforation
- Pelvic abscess or perforated tumor
- Pregnant or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty
The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.
Read the detailed description
Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.
- Conditions
- Rectal Cancer
- Being tested
- Gluteus plasty enhanced with Progrip self gripping mesh
- Keywords
- abdominoperineal resection, perineal reconstruction
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluteus plasty enhanced with Progrip self gripping meshProcedure or surgery
Intervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection.
| Study group | Role | What they receive |
|---|---|---|
| Gluteus plasty enhanced with Progrip self gripping mesh | Experimental | All study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction. Receives: Procedure: Gluteus plasty enhanced with Progrip self gripping mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Comprehensive complication index
Measured: 30 days
Secondary outcomes (9)
Surgical site infections
Surgical site infections
Measured: 30 days
Reoperation rate
Reoperation rate
Measured: 30 days
Operative time
Operative time to reconstruct perineum
Measured: 30 days
Length of hospital stay
Primary length of stay at the hospital
Measured: 30 days
Costs of treatment materials
Costs of treatment materials
Measured: 30 days
Total perineal healing time
Time from operation to complete perineal healing
Measured: 1 year
Perineal fistula
Perineal sinus or fistula
Measured: 30 days
Perineal hernia
Perineal hernia incidence
Measured: 12 months
Gluteus muscle function measured by time stands test
Gluteus muscle function measured by time stands test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start19 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients, who have an abdominoperineal reconstruction for rectal cancer, will have a mesh enhanced gluteus plasty. The patients will be compared to historical cohort.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Mäkäräinen, University of Oulu
- Investigators
- Tero Rautio, M.D. Ph.D., Study chair, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779125
- Sponsor's protocol ID
- 115/2020
- Status last verified
- Jan 2024
- First submitted
- 22 Feb 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apemesh II - Perineal Reconstruction With Mesh Enhanced Gluteus Plasty
- ClinicalTrials.gov ID
- NCT04779125
- Acronym / sponsor ID
- 115/2020
- Conditions
- Rectal Cancer
- Keywords
- abdominoperineal resection, perineal reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this pilot study is to assess the safety, functional outcome, feasibility and the potential benefits of synthetic mesh strip and gluteus flap reconstruction in perineum in case-control setting.
Detailed description
Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy seems to be a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients, who have an abdominoperineal reconstruction for rectal cancer, will have a mesh enhanced gluteus plasty. The patients will be compared to historical cohort.
| Arm | Type | Receives |
|---|---|---|
| Gluteus plasty enhanced with Progrip self gripping mesh | Experimental | Procedure: Gluteus plasty enhanced with Progrip self gripping meshAll study patietns will have a gluteus enhanced plasty after abdominoperineal reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Curative intent abdominoperineal resection and permanent colostomy
Key exclusion criteria (12 listed)
- Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4- 5)
- Immunosupression (cortisone >10mg/day) or severe malnutrition (BMI <20)
- Diabetes with 1 or more organ damage
- Dialysis treatment
- Hepatic cirrhosis Child-Bugh B-C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluteus plasty enhanced with Progrip self gripping meshIntervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection. | Procedure or surgery | Gluteus plasty enhanced with Progrip self gripping mesh |
Primary outcome
Complications
Time frame: 30 days
Comprehensive complication index
9 secondary outcomes
Surgical site infections
Time frame: 30 days
Reoperation rate
Time frame: 30 days
Operative time
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
Costs of treatment materials
Time frame: 30 days
Total perineal healing time
Time frame: 1 year
Perineal fistula
Time frame: 30 days
Perineal hernia
Time frame: 12 months
Gluteus muscle function measured by time stands test
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tero Rautio, M.D. Ph.D. study chair
Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluteus plasty enhanced with Progrip self gripping mesh in people with Rectal Cancer, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.